Zoryve FDA Approval History
Last updated by Judith Stewart, BPharm on May 27, 2025.
FDA Approved: Yes (First approved July 29, 2022)
Brand name: Zoryve
Generic name: roflumilast
Dosage form: Cream and Foam
Company: Arcutis Biotherapeutics, Inc.
Treatment for: Plaque Psoriasis, Atopic Dermatitis, Seborrheic Dermatitis
Zoryve (roflumilast) is a topical phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of plaque psoriasis (0.3% cream, 0.3% foam), atopic dermatitis (0.15% cream) and seborrheic dermatitis (0.3% foam).
- Zoryve is available in topical cream and foam formulations:
- Zoryve cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older.
- Zoryve cream 0.15% is indicated for the topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
- Zoryve foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older, and plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. - Zoryve contains roflumilast which is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4). PDE4 is an intracellular enzyme that drives overactive immune responses in a range of inflammatory diseases including psoriasis, eczema, and COPD.
- Roflumilast was first approved by the U.S. Food and Drug Administration (FDA) in 2011 as an oral formulation under the brand name Daliresp, which is used to reduce the risk of exacerbations of chronic obstructive pulmonary disease (COPD).
- Zoryve is applied to the affected areas once daily.
- Common adverse reactions:
- in patients using Zoryve cream 0.3% for plaque psoriasis include diarrhea, headache, insomnia, application site pain, upper respiratory tract infections, and urinary tract infections.
- in patients using Zoryve cream 0.15% for atopic dermatitis include headache, nausea, application site pain, diarrhea, and vomiting.
- in patients using Zoryve foam 0.3% for seborrheic dermatitis include nasopharyngitis, nausea, and headache.
- in patients using Zoryve foam 0.3% for plaque psoriasis of the scalp and body include headache, diarrhea, nausea, and nasopharyngitis.
Development timeline for Zoryve
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.